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705054

by Stryker Corp.

Ref 705054Model 08858251002548T7

705054 is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 08858251002548T7) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 07613327093391), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002548T7 Basic UDI-DI 07613327093391UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327093391 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002548T7 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 07613327093391 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327093391
  2. Registered EUDAMED 08858251002548T7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
AxSOS
Generic name
Bone tap, reusable
Device name
Axsos 3 Instruments - Tapping Instrumentation - Class Iia - Non Sterile
Model / Ref / Catalog
705054, 08858251002548T7
Primary DI / UDI-DI
07613327093391
Basic UDI-DI
08858251002548T7
Direct marketing DI
07613327093391
FDA product code
LXH
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Bone tap, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bone tap, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)